This invention relates to an apparatus and a method for minimizing, and most likely eliminating, contamination during an obstetrical delivery and repair.
In the pre-operative treatment of the obstetric patient in the labor room, it is sometimes customary to clean out the lower intestinal tract with an enema to evacuate most of the solid stool from the lower colon and rectum, hopefully to reduce contamination by stool at the time of delivery.
However, whether or not an enema is given, there is still considerable risk of contamination during delivery and repair. This is because the enema is generally not sufficient to provide for expulsion of all fecal material from the bowel. Hence, during delivery and repair great care is necessary to minimize the risk of contamination. Means to prevent expulsion of intestinal fluids and solids into the sterile, local site during delivery and subsequent repair is highly desirable.
One form of prior art device which has been suggested to avoid contamination is shown in U.S. Pat. No. 1,711,294 granted April 30, 1929 to G. Weitzner on an "Obstetric Device". This device comprises a flexible tube closed at one end, having a relatively rigid rim or ring surrounding the opening thereof and having a flexible sheet 10 surrounding the opening. Sheet 10 is provided with a skin adherent pressure sensitive adhesive 11 on the side which is to contact the perineum. This is a rectal closure device which is designed to hold back the intestinal contents before they are expelled through the use of a pouch or bag 14 for collecting fecal material and which is extruded from the rectum by the pressure of matter collecting therein. The device is not believed capable of solving the problem of contamination because the device will become detached and expelled during the severe pressures which occur during child birth. Further, the device may also become detached by the pressure of the collected fecal material. In addition, in the applicant's experience, the medical profession has been quite leery of devices which require insertion into the rectum.
The apparatus of the present invention is designed to greatly minimize contamination by directing fecal material from the rectal cavity away from the sterile, obstetric, operative site during delivery and repair. The apparatus is simple to apply, and yet is believed to effectively prevent contamination with fecal material even under the extreme pressures which often occur during child birth. Moreover, the apparatus of the invention achieves those objectives without being inserted into the rectum.
The apparatus of the invention preferably comprises a shield having a drape portion and an adhesive carrying surface zone above the drape portion. The shield is disposed to be positioned with drape portion locatable over the anus, and with the adhesive carrying surface zone adjacent to and in facing relation with the perineum and the perineal area. Moreover, at least a portion of the adhesive carrying surface zone is locatable between the vagina and the anal opening. In applying the apparatus, the adhesive carrying surface zone is pressed into tight engagement with the perineum and perineal area and the drape portion is positioned so as to guide or channel fecal material away from the sterile obsteric site during obstetrical delivery and repair.